Orthovita Announces Presentation of Cortoss 24-Month Pivotal Study Results at the 25th Annual Meeting of the North American Spine Society
MALVERN, Pa.–(BUSINESS WIRE)–Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, is pleased to announce that Hyun W. Bae, M.D., of The Spine Institute at Saint John’s Health Center in Santa Monica, California, will present an abstract entitled, “Correlation of Early Pain and Long-Term Functional Results from a Multi-Center, Prospective, Randomized, Controlled FDA-IDE Vertebroplasty Trial,” at the 25th Annual Meeting of the North American Spine Society (NASS) being held October 5-9, 2010 at the Orange County Convention Center in Orlando, Florida. The presentation will take place on Friday, October 8, 2010 at 7:37 a.m. The abstract has been selected for presentation during the prestigious Friday Best Papers session of the meeting.
“Correlation of Early Pain and Long-Term Functional Results from a Multi-Center, Prospective, Randomized, Controlled FDA-IDE Vertebroplasty Trial”
Dr. Bae’s abstract is based on clinical data from Orthovita’s multi-center, prospective, randomized, investigational device exemption (IDE) study. In this study, the safety and efficacy of Orthovita’s Cortoss™ Bone Augmentation Material was compared to a polymethylmethacrylate (PMMA) control in the treatment of vertebral compression fractures. Dr. Bae participated in the study as a clinical investigator.
In this study, the safety and effectiveness of Cortoss was found to be non-inferior to the control. In addition, key findings from the 256-patient clinical study include the following statistically significant benefits for the Cortoss patient group:
- Early patient outcomes assessed at 3 months: With 86.6% of Cortoss patients and 75.0% of PMMA patients achieving successful pain relief as measured by the Visual Analogue Pain Scale (VAS), the Cortoss patient group experienced a statistically significant benefit in pain success over the PMMA group.
- Long-term patient outcomes assessed at 24 months: With 96.7% of Cortoss patients and 88.4% of PMMA patients maintaining or improving their function as measured by the Oswestry Disability Index (ODI), the Cortoss patient group experienced a statistically significant benefit in function success over the PMMA group.
In addition to the statistically significant benefit in pain success at three months and function success at 24 months, the Cortoss population experienced measurable benefits over the PMMA cohort in the following outcomes:
- A 43.4% reduction in subsequent, adjacent level fractures in Cortoss patients treated for a primary fracture at one level, as measured at the end of the 24-month follow-up period.
- An average of 30% less material was required to achieve adequate fracture fill in Cortoss patients.
Dr. Bae stated, “On behalf of my co-investigators, I’d like to express our appreciation to NASS for having selected our work in vertebroplasty as one of the Best Papers for this year’s meeting. With all of the discussions surrounding vertebral augmentation that are taking place today, this Level I study provides important evidence that should be included in the debate. The results show that the majority of properly selected vertebroplasty patients experience early, substantial and sustained reduction in pain and improvement in function. Furthermore, the results show that the improved material characteristics of Cortoss as compared to PMMA do lead to measurable improvements in outcomes.”
This most recent presentation at NASS represents the culmination of over a decade of pre-clinical and human clinical research on Cortoss Bone Augmentation Material. Since 1999, this research has been highlighted in 49 podium and 33 poster presentations at a variety of national and international specialty society meetings, as well as published in 18 peer-reviewed, scientific journals. “Orthovita would like to join the investigators in expressing its appreciation for NASS’s recognition, which confirms the quality of the IDE study. The sheer number and nature of scientific presentations over the years reflect our commitment to develop and clinically evaluate this unique material, for which we plan to seek regulatory clearance in additional indications,” said Maarten Persenaire, M.D., Chief Medical Officer.
About the Company
Orthovita is an orthobiologics and biosurgery company that develops and markets novel medical devices. Our orthobiologics platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VITOSS™ Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CORTOSS™ Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. Our hemostasis portfolio includes VITAGEL™ Surgical Hemostat, a unique, collagen-based matrix that controls bleeding and facilitates healing, and VITASURE™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the demand and market acceptance of our products and other aspects of our business and our ability to obtain regulatory clearance for additional indications for Cortoss. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption “Risk Factors.” Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
